Safety, Tolerability, PK and Food Effect of RV299 in healthy adults
Research type
Research Study
Full title
A randomised, double blinded, placebo-controlled single and multiple ascending dose study of orally administered RV299 to evaluate safety, tolerability, pharmacokinetics and food effect in healthy adult participants
IRAS ID
302644
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
ReViral Ltd
Eudract number
2021-003521-29
Duration of Study in the UK
0 years, 9 months, 20 days
Research summary
RV299 is an investigational drug under development for the treatment of respiratory syncytial virus (RSV). RV299 works by preventing replication of the virus. This is a first in human study.
Respiratory Syncytial virus (RSV) causes disease in the very young, the immunocompromised, and the elderly. In these groups, the disease can be particularly dangerous. It is highly infectious and is transmitted through respiratory secretions via close contact with infected individuals, through droplets, or through contaminated surfaces. Currently, there are few treatment options available and no vaccine to prevent infection exists.
Richmond Pharmacology are conducting a clinical trial aimed at investigating the safety, tolerability, pharmacokinetics and food effect of RV299. The study will involve three parts and one optional additional part. A maximum of 104 participants will be included in up to 15 cohorts. Screening will be undertaken over a 20-day period prior to admission for the study procedures on D-2. Depending on the study part, dosing will either occur on a single day or across multiple days, as described in the study protocol.
The main objective of the study is to establish the safety and tolerability of RV299 following single and multiple dosing in healthy adult Caucasian (and possibly Japanese, in an optional cohort) subjects.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0231
Date of REC Opinion
18 Oct 2021
REC opinion
Favourable Opinion